Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain

NCT06921174 | Recruiting Phase 2 DMC

• 1 other identifier: C.P. ISM-CRE-2024-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

GA34.01 postpartum, a randomized design with a parallel group structure will be applied, randomly assigning participants into two groups. The first group will receive the traditional perineal massage therapy, while the second group will use the intravaginal device "Crescendo 2." In this study, a pre- and post-intervention evaluation will be conducted, using the Visual Analog Scale (VAS) as the primary outcome measure and the Clinical Global Impression Scale as the secondary outcome measure.

Conditions

Pelvic Pain

Keywords

postpartum pelvic pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) - to assess pain intensity

  The \*\*Visual Analogue Scale (VAS)\*\* will be used as the \*\*primary outcome measure\*\*. It consists of a horizontal line approximately 10 centimeters long. At each end of the line are the extreme expressions of pain: on the left, "no pain," and on the right, "worst imaginable pain." This tool allows us to measure the intensity of pain with high reproducibility between observers. Visual Analogue Scale (VAS): The Visual Analogue Scale is a psychometric response scale used to measure pain intensity. It typically consists of a 10-centimeter horizontal line anchored by two verbal descriptors: "no pain" (score = 0) and "worst imaginable pain" (score = 10). Minimum score: 0 (no pain) Maximum score: 10 (worst imaginable pain) Interpretation: Higher scores indicate worse outcomes (i.e., more intense pain).

  First measure week 1 and Last measure week 12

Secondary Outcomes (1)

• Clinical Global Impression (CGI) - for overall health status

  At the end of the treatment week 12

Study Arms (2)

Classical Perineal Massage Therapy

ACTIVE COMPARATOR

Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.

Procedure: Classical Perineal Massage Therapy

Use of the "Crescendo 2" Intravaginal Device

EXPERIMENTAL

Self-administered perineal massage at home. Three times per week, 10 minutes each session, over a 12-week period.

Device: Use of the "Crescendo 2" Intravaginal Device

Interventions

Use of the "Crescendo 2" Intravaginal Device DEVICE

Self-administered perineal massage at home with Crescendo device. Three times per week, 10 minutes each session, over a 12-week period.

Use of the "Crescendo 2" Intravaginal Device

Classical Perineal Massage Therapy PROCEDURE

Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.

Classical Perineal Massage Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or older.
• Residing in the Region of Murcia.
• Having had a vaginal delivery between 6 weeks and 12 months prior to enrollment.
• Presenting postpartum perineal pain, coded in ICD-11 as GA34.01.
• Have not received any prior treatment for this condition.

You may not qualify if:

• Presence of severe conditions such as:
• Excessive postpartum hemorrhage
• Serious infections
• Respiratory or circulatory complications
• Neurological disorders requiring intensive medical intervention
• Currently under pharmacological treatment for pelvic pain.
• Active vaginal infections.
• Expressed refusal to participate or inability to comply with study procedures.
• Women with episiotomy may participate only if there were no complications such as severe infection or hemorrhage following the procedure.
• Willingness to participate and to follow the study protocol.

Sponsors & Collaborators

• Instituto Sexológico Murciano: lead
• CIAGO - Center for Comprehensive Gynecology and Obstetrics: collaborator
• Carmen Parra Pilates Center: collaborator

Study Sites (1)

Instituto Sexológico Murciano

Murcia, Murcia, 30007, Spain

RECRUITING

Related Publications (2)

• Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet. 2002 Feb 9;359(9305):515-9. doi: 10.1016/S0140-6736(02)07683-3.

  PMID: 11853818 BACKGROUND

• Beckmann MM, Garrett AJ. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005123. doi: 10.1002/14651858.CD005123.pub2.

  PMID: 16437520 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jesús Eugenio Dr. Rodríguez Martínez, Phd

CONTACT

+34639238413; jesuseugenio@isemu.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Type: Randomized Controlled Trial (RCT) Structure: Two parallel groups (random assignment)

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 10, 2025
• Study Start: March 27, 2025
• Primary Completion: June 1, 2025
• Study Completion: August 31, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)